23andMe relaunches direct-to-consumer tests for genetic disease

23andMe relaunches direct-to-consumer tests for genetic disease

来源：未知 作者：寇莜峻 时间：2017-04-24 04:01:22

By Helen Thomson What are the odds of that? 23andMe is relaunching its direct-to-consumer genetic tests after gaining government approval for a more limited array of tests to inform you about your risk of passing on a genetic disease. In 2013, the company was banned from selling a genetic test that provided customers with information about their risk of developing 254 conditions, including breast cancer, Alzheimer’s and heart disease. The US Food and Drug Administration (FDA) said the company had not proved that it had clinically validated their tests for their intended uses. Nearly two years on, 23andMe has announced that it will resume selling a genetic health testing kit, which is based on a sample of saliva, although it will include tests for fewer diseases, all of which have been FDA approved. The company has also redesigned its website to make personalised genetic information easier to understand and increased the price of the test from $99 to $199. “We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,” said Anne Wojcicki, CEO of 23andMe, in a statement. “We are a better company with a better product as a result of our work with the FDA.” 23andMe will provide customers with data based on “carrier information” about genetic mutations that could lead to disease in offspring. The kit includes tests for 36 diseases, such as sickle cell anaemia and cystic fibrosis. The new product is very different from 23andMe’s previous offering – its “Personal Genome Service” – which attempted to provide customers with an estimation of risk for 254 different conditions. One of the concerns regarding the results of this service was that they did not reflect the effect of environmental influences on many of the diseases. The risk estimates were also difficult to interpret without the guidance of a medical professional. “The new product focuses on carrier mutations, or specific gene changes, known to cause health issues when children receive the mutations from both parents,” says Brian Zikmund-Fisher at the University of Michigan School of Public Health, Ann Arbor. “Issues like behaviour and environment don’t generally matter for these diseases. If environment and behaviour do matter, they matter in determining how and when a condition shows itself, not whether it will happen.” The company is not testing for the conditions that raised the most concerns last time, such as heart attack, asthma and hip fractures, for which lifestyle factors are often more important, says Cecile Janssens an epidemiologist at Emory University in Atlanta, Georgia. Janssens adds that the company is also refraining from testing for high-risk genetic mutations to genes such as BRCA1 and BRCA2, which are related to developing breast and ovarian cancer and to APOE, which are linked to Alzheimer’s. “It will be most interesting to follow what the FDA is going to decide for these tests,” she says. Like this? Read Doctor You: Home diagnosis gadgets are here for real Image credit: ZUMA Press/Alamy Stock Photo More on these topics: